Method for deep tissue laser treatments using low intensity laser therapy causing selective destruction of Nociceptive nerves

ABSTRACT

Deep Tissue Low Intensity Laser Therapy or Treatment (DT-LILT) as described here is a novel methodology through which selective destruction of nociceptive (pain) nerves can be brought upon by a medical laser delivery system using the phenomenon of absorption and cell resonance. Using this method nerve cells that transmit pain can be selectively destroyed leaving the surrounding tissues intact as no heat is generated. The delivery system incorporates a fine needle through which a 703 nm (range 690 to 710) pulsed wave low intensity laser is delivered deep into the body, directly to the area of pain causing selective destruction of pain nerves. Laser devices based on this methodology should be used only by the physician or equivalent professional community since diagnosing and defining the area of pain is critical to providing successful pain relief. 
     Key Words: DT-LILT (Deep Tissue Low Intensity Laser Therapy or Treatment)

TECHNICAL FIELD

This application relates to laser medical devices and its use in pain medicine.

BACKGROUND OF THE INVENTION

Low level laser therapy (LLLT), also known as photobiomodulation, cold laser therapy, and laser biostimulation, is a medical and veterinary treatment, which uses low-level lasers or light-emitting diodes to stimulate or inhibit cellular function. LLLT uses light sources such as lasers or LEDs to deliver light of certain wavelengths at certain intensities to affect tissue regeneration, inflammation, or pain. Existing deep tissue lasers today use heat generation to cause a non-selective action destroying non-specific tissue on contact.

SUMMARY

In general, one aspect of the subject matter described in this specification may include using a deep tissue low intensity laser (DT-LIL) capable of producing cell resonance within a nerve cell that can selectively cause destruction of the nerve cells without affecting the surrounding tissues. The deep tissue low intensity laser treatment (DT-LILT) selectively destroys nerve cells on contact using absorption and cell resonance. DT-LILT does not generate sufficient heat to destroy tissue, allowing selective destruction when nerve cells selectively absorb the DT-LILT wavelength. Thus, selective deep tissue low intensity laser ablation (DT-LILA) of the nerves, or deep tissue low intensity laser neuroablation (DT-LILNA) takes place.

The selection of laser wavelength may depend on the absorption characteristics of the nerve cells. Heat may or may not be generated as the selective destruction takes place by cell resonance rather than by heat coagulation. The use of deep tissue low intensity laser neuroablation (DT-LILNA) is described herein and is different from other medical or tissue lasers that use heat generation. Clinical applications include treating chronic pain, soft tissue injury, wound healing and nerve regeneration.

DEFINITION OF TERMS

1. DT-LILT: Deep Tissue Low Intensity Laser Treatment or Therapy.

2. DT-LIL: Deep Tissue Low Intensity Laser.

3. DT-LILA: Deep Tissue Low Intensity Laser Ablation.

4. DT-LILNA: Deep Tissue Low Intensity Laser Neuroablation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a schematic diagram of an example laser delivery system for use with DT-LILT.

FIG. 2 illustrates an AP x-ray view of a lumbar facet joint, a lamina and a spinous process.

FIGS. 3A-3G illustrate single lumbar facet joints with various laser point configurations for DT-LILT.

FIG. 4 illustrates an example laser delivery system for use with DT-LILT.

In the drawings, like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

Current deep tissue medical lasers are typically high intensity lasers, with output powers usually around 100 mW or above, that generate heat to destroy contact tissue using techniques such as hemo-coagulation. However, these deep tissue medical lasers lack sufficient selectivity or specificity to destroy contact tissue without causing collateral damage to surrounding tissue. Traditional low level laser therapy (LLLT) techniques also lack sufficient specificity. Current LLLT techniques use indirect pain relief techniques such as minimal heat generation, vasodilatation or metabolic changes. These lead to temporary pain relief because they do not destroy problematic pain nerves that cause long-term pain.

The deep tissue low intensity laser treatment (DT-LILT) disclosed in this application selectively destroys nerve cells on contact using the phenomenon of absorption and cell resonance. DT-LILT does not generate heat, or the heat generated is not sufficient to destroy tissues, therefore selective destruction is brought upon by cell resonance when the nerve cells selectively absorb the DT-LILT laser wavelength. By causing destruction of nerve cells in this manner, DT-LILT can provide long-term pain relief extending for many months.

FIG. 1 illustrates a schematic diagram of an example laser delivery system 100 for use with DT-LILT. For example, the system 100 may include a laser generator 102, a laser fiber 104, a laser fiber fixator 106, and a needle 108. The system 100 may be used in DT-LILT by performing absorption and cell resonance to selectively destroy nerve cells without affecting the surrounding tissues.

In some implementations, the system 100 is used to specifically destroy nerve cells to provide long-term pain relief. This is performed by causing absorption of specific wavelengths by nociceptive nerves when DT-LILT is directly applied to a pain generating area, bringing about the physiologic action of neuroablation (DT-LILNA) of the pain nerves. In such implementations, the DT-LILT may be minimally invasive and designed to be used within the pain generating area. For example, DT-LILT may be applied to specific areas of the spine as shown in FIGS. 3A-3G. The system 100 may be used to cause destruction of tissue without heat generation. For example, laser generator 102 may be a DT-LIL with power output less than 5 mW to allow deep tissue application. In some implementations, the DT-LIL may fall under laser classification 3R or below.

In one implementation, the system 100 includes the laser generator 102 capable of generating light of wavelength in the 690 nm to 710 nm range, the laser fiber 104 with diameters between 0.7 and 0.5 mm, and the laser fiber fixator 106 coupled with the needle 108 using a luer lock mechanism. The needle 108 may be a common Quincke spinal needle. The fixation between the laser fiber 104 and the spinal needle 108 can also be achieved by making the laser fiber and the spinal needle as one non detachable unit.

In some implementations, the laser generator 102 produces a laser with wavelength between 700 nm to 705 nm, laser output average power between 4 mW and 6 mW (with range between 1 mW and 6 mW), a laser pulsation at nanosecond or picosecond intervals, and timer controlled between 5 seconds and 10 seconds.

In some implementations, the nerve tissue consists of lipids that absorb the above laser wavelengths without impacting surrounding non-nervous tissue. For example, the laser generator 102 may have a wavelength between 690 nm and 710 nm with an optimal absorption at 703 nm, and with low output and high pulsation, which is absorbed by the nociceptive nerves. In such an example, using a 703 nm laser with the low output and high pulsation causes the nociceptive nerves to be selectively destroyed leaving surrounding tissue intact without heat generation.

In some implementations, the needle 108 is a fine needle that is 22G or smaller to deliver the laser treatment deep into the tissue. In some implementations, the needle 108 is 25G with a 0.5 mm inner diameter to fit a 300 μm laser fiber 104 and insert the laser fiber 104 below the body surface of a human patient. The fine needle 108 facilitates reaching tissue areas of treatment that may lie deep from the body surface and the inserted laser fiber facilitates the laser delivery to the area of treatment. In some implementations, the needle 108 may be a Quincke spinal needle. The fine needle 108 may provide cost savings as compared to heavier and bigger conduits for laser delivery.

In some instances, the design of the needle 108 includes laser fiber 104 embedded within the cannula of the needle to form a non-detachable unit. In some instances, the system 100 includes a laser fiber fixator 106 with a luer lock mechanism to facilitate the attachment of different-sized syringes to various sized needles. For example, the laser fiber fixator 106 with a luer lock mechanism may be used to attach the needle 108, which may be a Quincke spinal needle, to the laser fiber 104, which fixes the laser fiber within the needle and prevents movement of the fiber during laser delivery. In some implementations, the laser fiber fixator 106 includes a tuohy borst adapter with a blue cap and a male luer lock connector with a spin lock. In such implementations, the dimensions of the laser fiber fixator 106 may be between 2-6 FR (0.026 in-0.083 in) (0.66 mm-2.11 mm) (22-12 Gauge). In such implementations, the material of the laser fiber fixator 106 may be acrylic, polycarbonate, or silicone.

In some implementations, the system 100 may be used to perform a method that includes an intra-operative treatment using facet joint neuroablation, also known as medial branch neuroablation, as represented in FIG. 2. For example, the method may use a simple AP x-ray view and pass a deep tissue low intensity laser to cause a DT-LILNA. In another example, the DT-LIL may cause a DT-LILA. This is in contrast to conventional neuroablation that is based on finding the medial branch nerve in an oblique/lateral X ray view and using heat or chemical substance to destroy the medial branch.

FIG. 2 illustrates an AP X-Ray view of lumbar facet joints 202, a lamina 204 and a spinous process 206. DT-LILT may be applied to specific areas of the spine as shown in FIG. 2, using laser points as shown in FIGS. 3A-3G.

Although FIG. 2 shows the lumbar facet joint as laser points for the application of DT-LILT using the laser delivery system 100, the laser points used in DT-LILT are also applicable to all facet joints, including thoracic and cervical facet joints. When the size of the facet joint is smaller, the laser points and the laser area for DT-LILT may reduce but the pattern of laser delivery remains the same.

FIGS. 3A-3G illustrate single lumbar facet joints with various laser point configurations for DT-LILT. Referring to FIG. 3A, laser points 312 may be made in eight points in a circular fashion around the facet joint 310. Referring to FIG. 3B, laser points 322 may be made in a continuous circular fashion around the facet joint 320. Referring to FIG. 3C, the laser points 332 may be made in continuous intermittent fashion around the facet joint 330. Referring to FIG. 3D, the laser points 342 may be made in continuous cross fashion across the facet joint 340. Referring to FIG. 3E, the laser points 352 may be made in continuous multiple cross fashion across the facet joint 350. Referring to FIG. 3F, the laser points 362 may be made in continuous intermittent fashion 4 across the facet joint 360. Referring to FIG. 3G, the laser points 372 may be made in a continuous intermittent fashion multiple across the facet joint 370.

FIG. 4 illustrates an example laser delivery system 400 for use with DT-LILT. The laser delivery system 400 may be used for a medical procedure for treating reoccurring pain. In some implementations, the laser delivery system 400 is similar to the system 100.

In some implementations, the system 100 or the system 400 includes specified operating parameters for DT-LILT. For example, the laser generator 102 generates a 703 nm wavelength laser with 2 nm specified range, has an average 4 mW output power with a 0.8 mW specified range and a peak output power at 40 nW with 8 nW specified range. The laser is pulsed at 25 ns and is timer controlled at 5 s or 10 s. The system 100 or the system 400 includes two types of laser fiber diameters at 200 micron and 300 micron, with a laser area of the tissue under treatment that is confined to the laser fiber diameter with less than 1 mm scatter.

The laser also operates on rechargeable batteries, does not require a dedicated power supply during operation, and is compatible with the North American 110-120 V/AC standard. The system 100 or the system 400 is also enclosed in a non-conducting insulated casing and does not require separate grounding during charging, operation, or both. In such implementations, because the laser has low output power, its use for pain treatment is safer than current deep tissue medical lasers with high intensity lasers.

The following sections describe an example DT-LILT procedure using the system 100 or the system 400 in some implementations. The DT-LILT procedure in these implementations does not involve use of sedation, general anesthetics, local anesthetics, or the use of oral or injectable drugs. The DT-LILT is performed bilaterally on the L5-S1 and L4-L5 face joints. During the procedure, a 25 G spinal needle is initially directed bilaterally at each of the L4-L5 and L5-S1 facet joints. Each facet joint is individually treated. Once the needle is embedded at the center of the facet joint, the laser fiber is inserted after removing the stylet. The DT-LILT generator is then switched on to deliver five seconds of laser energy.

In this manner, four facet joints are treated with one laser delivery point per facet joint with a five second laser delivery time and a 20 second total laser delivery time during the procedure. During the procedure, the patient is aware of the entire procedure to provide feedback. The patient may not feel discomfort other than from insertion of the needle.

During post procedure testing, which is performed to determine the effectiveness of the procedure in reducing or removing pain symptoms, pain resolution report from the patient is collected and the patient's ability to stand straight, flex the spine posteriorly are all evaluated. A Kemp test is also performed to assess the lumbar spine facet joints. A patient satisfaction score from a scale 0 to 100 (higher the score better the satisfaction) may be collected to determine pain reduction resulting from the procedure.

Results of test applications of DT-LILT indicated complete 100% resolution of pain symptoms after the procedure, with the patient able to stand straight and flex the spine posteriorly. The patient had negative Kemp test soon after the procedure. The patient also reported a satisfaction score of 100. 

The invention is claimed as follows:
 1. A method of laser therapy for treatment of pain conditions by selective non-thermal destruction of Nociceptive nerves that are conducting pain, comprising: determining a laser point on a human body for application of a low intensity laser beam; inserting a spinal needle into the human body at the determined laser point to contact the spinal needle's distal tip with Nociceptive nerves that are conducting pain; selecting a laser wavelength in a range between 700 nm to 705 nm; generating a low intensity pulsed laser beam at the selected laser wavelength with an average output power in a range between 1 mW and 6 mW and with a known pulse duration in a range of nano-seconds or pico-seconds; transmitting the laser beam through a laser fiber to emerge at the spinal needle's distal tip to contact the Nociceptive nerves; and applying the low intensity pulsed laser beam at the selected laser wavelength and with the known pulse duration to the Nociceptive nerves for a time interval between 5 seconds and 10 seconds to induce absorption of the laser beam by the Nociceptive nerves for generating non-thermal nerve cell resonance of the Nociceptive nerves.
 2. The method of claim 1, wherein generating the low intensity pulsed laser beam comprises: configuring a laser generator to provide the average output power in a range between 3.2 mW and 4.8 mW.
 3. The method of claim 1, wherein the laser fiber is fixedly inserted within a hollow cavity of the spinal needle to the spinal needle's distal tip, the method further comprising: attaching the laser fiber to the spinal needle by using a Luer lock mechanism, whereby the laser fiber and the spinal needle operate as one non-detachable unit without any movements there between and without any displacement of the laser fiber within the hollow cavity of the spinal needle.
 4. The method of claim 1, wherein applying the low intensity pulsed laser beam for the time interval between 5 seconds and 10 seconds comprises: configuring a timer with a preset time interval for application of the laser beam, wherein the preset time interval includes one of 5 seconds or 10 seconds.
 5. The method of claim 1, wherein inserting the spinal needle into the human body at the determined laser point comprises: guiding the spinal needle by clinical diagnosis and fluoroscopy to the Nociceptive nerves.
 6. The method of claim 1, wherein determining a laser point on a human body for application of the low intensity laser beam comprises: selecting a specific pattern of laser beam contact with the Nociceptive nerves at lumbar spinal facet joints of the human body, wherein the specific pattern is selected from the group consisting of 8 points in a circle around the facet joints; a continuous circle around the facet joints; 4 quadrants circled around the facet joints; a continuous cross pattern on the facet joints; continuous multiple cross patterns on the facet joints; multiple points forming a cross pattern on the facet joint; and multiple points forming multiple cross patterns on the facet joints.
 7. The method of claim 1, wherein the laser fiber is selected based on a diameter of the laser fiber that includes one of 200 micron or 300 micron.
 8. The method of claim 1, wherein the pulse duration includes 25 nano-seconds.
 9. The method of claim 1, wherein generating the low intensity pulsed laser beam comprises: configuring a laser generator to generate the low intensity pulsed laser beam with a laser output peak power of 40 nano-watts.
 10. The method of claim 9, wherein the laser output peak power includes a range of +/−8 nano-watts around 40 nano-watts.
 11. The method of claim 1, further comprising: limiting an area of application of the laser beam to the Nociceptive nerves based on a diameter of the laser fiber.
 12. The method of claim 1, wherein the spinal needle includes a 22G or smaller spinal needle.
 13. The method of claim 1, wherein the spinal needle includes a 25G spinal needle that has an inner diameter of 0.5 mm.
 14. The method of claim 3, wherein the spinal needle includes a Quincke spinal needle.
 15. The method of claim 1, wherein the spinal needle is selected based on a diameter of the spinal needle.
 16. The method of claim 15, wherein the diameter of the spinal needle is determined to limit the area of application of the laser beam to the Nociceptive nerves.
 17. The method of claim 1, wherein the laser fiber is selected based on a diameter of the laser fiber that is less than 0.7 mm.
 18. The method of claim 1, wherein generating the low intensity pulsed laser beam comprises: configuring a laser generator to provide the average output power in the range between 1 mW and 6 mW.
 19. The method of claim 1, further comprising: destroying the Nociceptive nerves without destroying surrounding nerves that are not conducting pain and without destroying surrounding tissues based on generating the non-thermal nerve cell resonance of the Nociceptive nerves and limiting the area of application of the laser beam to the Nociceptive nerves. 